开发和分析日本现代综合性临床数据管理培训计划
Takuhiro Yamaguchi1,2,3, Hiroko Yaegashi2,4, Shih-Wei Chiu1,2
1Clinical Research Data Center, Tohoku University Hospital, Japan.
Heliyon
|March 28, 2024
概括
这项研究为日本专业人员开发了一项先进的临床数据管理 (CDM) 培训计划. 该计划涵盖基于风险的监测和数据标准,获得了高满意度评分,表明其有效性.
科学领域:
- 临床研究 临床研究
- 数据管理数据管理
- 专业教育 专业教育 专业教育
背景情况:
- 临床数据管理 (CDM) 对临床研究至关重要,涉及数据收集,集成和可访问性.
- 在日本的学术研究组织中,对于CDM存在有限的系统培训框架.
- 现有的日语CDM培训的有效性需要进一步评估.
研究的目的:
- 为临床数据管理专业人员开发先进的教学计划.
- 在日本背景下评估开发的CDM培训计划的有效性.
主要方法:
- 设计了一个先进的CDM程序,结合了基于风险的监测和临床数据交换标准联盟 (CDISC) 的原则.
- 该计划与临床数据管理人员进行试点测试,以确保对CDM的全面理解.
主要成果:
- 52名专业人士参与了试验计划.
- 参与者对培训内容和交付表示高度满意.
结论:
- 持续改进CDM培训内容和高级程序开发对于日本的综合教育至关重要.
- 基于能力的教育计划需要进一步加强,因为不断变化的临床研究法规和技术进步.
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